Bio Pharma Dive
AUGUST 8, 2023
The job cuts will affect “all areas of the company” and, combined with other cost-reduction efforts, lead to annualized savings of over $100 million, Emergent said.
Pharmaceutical Technology
AUGUST 8, 2023
Jacobio Pharma received breakthrough therapy designation (BTD) for glecirasib to treat pancreatic cancer patients with the KRAS G12C mutation.
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Bio Pharma Dive
AUGUST 8, 2023
The Indianapolis drugmaker is now worth more than $500 billion, higher than any other pharmaceutical company, as analysts project lucrative markets for its obesity and Alzheimer's drugs.
Pharmaceutical Technology
AUGUST 8, 2023
An increasing amount of information make artificial intelligence (AI) stand out as a promising solution to improve the provision of healthcare.
Bio Pharma Dive
AUGUST 8, 2023
Treatment with Wegovy led to a 20% reduction in the relative risk of cardiovascular complications or death, a finding that could further shift how doctors treat obesity.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 8, 2023
Each cigarette sold in Canada will have to come with an individual health warning that “cigarettes cause impotence” and cancer, and that there is “poison in every puff” under new rules that came into effect Tuesday. The new regulations, which were first announced in May, are a world first.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 8, 2023
To help the pharmaceutical companies located in Baddi and in Solan district of Himachal Pradesh (HP) to better their performances further, the Baddi Barotiwala Nalagarh Development Authority (BBNDA), under the Government of HP, will organize a National Pharma Summit in September in which all stakeholders of the Indian pharmaceutical sector and government officials of the […]
Pharmaceutical Technology
AUGUST 8, 2023
Pricing and reimbursement of pharmaceuticals is changing in Sweden, with prices lower than average as a result of growing cost containment strategies. Here’s what you need to know.
Rethinking Clinical Trials
AUGUST 8, 2023
From left: Dr. Steven George, Dr. Vincent Mor, and Dr. Angelo Volandes In an interview at this year’s NIH Pragmatic Trials Collaboratory Steering Committee annual meeting, Drs. Steven George, Vincent Mor, and Angelo Volandes discussed the complexity of intervention delivery in pragmatic clinical trials and the impact it can have on researchers’ ability to discern trial results. “Without delving deeply into the way in which an intervention can be integrated into an operating sys
Pharmaceutical Technology
AUGUST 8, 2023
Ahead of Eli Lilly's Q2 results, which will likely touch on the company's plans for obesity drugs, we take a look at the ongoing discourse on this drug class
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Rethinking Clinical Trials
AUGUST 8, 2023
Pilot-Testing Interventions in Pragmatic Trials: SPOT Case Study Description Dr. Greg Simon discusses pilot testing interventions in embedded pragmatic clinical trials (ePCTs). Biography Gregory Simon, MD, MPH Senior Investigator, Kaiser Permanente Washington Health Research Institiute SPOT Demonstration Project PI Health Care Systems Interactions Core Chair Coordinating Center Leadership The post Pilot-Testing Interventions in Pragmatic Trials: SPOT Case Study appeared first on Rethinking Clini
Pharmaceutical Technology
AUGUST 8, 2023
The US Food and Drug Administration (FDA) has accepted for review Viatris and Mapi Pharma’s new drug application (NDA) filed for GA Depot.
Rethinking Clinical Trials
AUGUST 8, 2023
Including Diverse Participants in Pragmatic Clinical Trials Description Dr. Rosa Gonzalez-Guarda of Duke University, Dr. Rachel Gold of the Kaiser Permanente Center for Health Research, and Dr. Karen Kehl of the National Institute of Nursing Research discuss the important of including diverse participants in pragmatic trials, including highlights from a panel discussion at the NIH Pragmatic Trials Collaboratory 2022 Steering Committee Meeting.
Pharmaceutical Technology
AUGUST 8, 2023
The deal sets the biosimilar’s potential US launch date to no later than April 2025, following two agreements signed earlier this year.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Rethinking Clinical Trials
AUGUST 8, 2023
Ethical Considerations for Data Sharing in Pragmatic Trials Description Dr. Stephanie Morain of Johns Hopkins University discusses a supplemental grant award to the NIH Pragmatic Trials Collaboratory Coordinating Center to study the ethical issues that arise in data sharing in the context of pragmatic trials. Biography Stephanie Morain, PhD, MPH Assistant Professor, Bloomberg School of Public Health, Johns Hopkins University Ethics and Regulatory Core Co-chair The post Ethical Considerations for
Pharmaceutical Technology
AUGUST 8, 2023
Danam Health has signed a merger deal with publicly traded special purpose acquisition company (SPAC) Artemis Strategic Investment.
Rethinking Clinical Trials
AUGUST 8, 2023
Implementation and Intervention Complexity in Pragmatic Clinical Trials Description Dr. Steven George of Duke University discusses implementation and intervention complexity in pragmatic trials, including highlights from a panel discussion at the NIH Pragmatic Trials Collaboratory's 2022 Steering Committee Meeting. Biography Steven George, PhD Professor in Orthopaedic Surgery, Duke University Related Read our news and view the full presentation.
Pharmaceutical Technology
AUGUST 8, 2023
Ginkgo Bioworks has entered into a new partnership with Merck (MSD) to bolster biologic manufacturing in a deal worth up to $490m.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
BioPharma Reporter
AUGUST 8, 2023
A new report from Angelini Pharma has highlighted an ongoing treatment gap for epilepsy care in Europe, including significant differences in access to treatment between countries.
Pharmaceutical Technology
AUGUST 8, 2023
However, the adenosine receptor antagonist is still being developed for the treatment of metastatic colorectal cancer.
Antidote
AUGUST 8, 2023
Persistent corneal epithelial defects are more than just an eye injury. The corneal epithelium is an integral part of the eye , tasked with guarding against infection and structural damage. While most injuries to the corneal epithelium are able to heal within a week , these persistent injuries will continue well past the seven-day mark. If they remain unresponsive to standard treatments, the condition is referred to as a persistent corneal epithelial defect.
Pharmaceutical Technology
AUGUST 8, 2023
Wegovy has been approved in the US and Europe for weight loss management in patients aged 12 years and older.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Drug Discovery World
AUGUST 8, 2023
The second quarter of 2023 has seen steady growth in financing activity for the UK’s life sciences sector, according to new data released by the BioIndustry Association (BIA) and Clarivate. The positive news comes soon after industry figures welcomed recent announcements to unlock new sources of capital in the City of London. Last month, the UK Chancellor and the Lord Mayor of London launched Mansion House Compact, which is an agreement by pension providers to allocate a minimum 5% to unlisted e
Drug Patent Watch
AUGUST 8, 2023
A recent study explores the landscape of authorized generics in the United States pharmaceutical market. Authorized generics are brand-name drugs that are marketed without their original branding. The article sheds… The post Prevalence and timing of authorized generics in the US market appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
AUGUST 8, 2023
Astex Pharmaceuticals and MSD (Merck & Co) have announced an exclusive worldwide research collaboration to identify small molecule candidates with activity towards a tumour suppressor protein for the treatment of cancer. Under the terms of the agreement, Astex will apply its fragment-based drug discovery platform to develop compounds targeting multiple forms of the p53 tumour suppressor protein and provide MSD with lead compounds for further optimisation and preclinical development.
Fierce Pharma
AUGUST 8, 2023
Novo Nordisk has been riding the momentum of weight loss drug Wegovy ever since it stormed onto the market in 2021, creating widespread hype and even some supply shortfalls. | In a large phase 3 trial, Wegovy cut the risk of major adverse cardiovascular events by 20% compared with placebo and standard of care, Novo said Tuesday. Specifically, investigators measured Wegovy's 2.4-mg dose for its ability to cut the risk of a cardio death, heart attack or stroke.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Pharma Times
AUGUST 8, 2023
Tezspire is a drug for severe asthma and Forxiga is used to treat chronic heart failure - News - PharmaTimes
Fierce Pharma
AUGUST 8, 2023
It took Bayer’s new CEO Bill Anderson about 20 seconds into his first quarterly conference call to go against the grain. | In his first quarterly earnings call since taking over as CEO at Bayer, Bill Anderson faced several questions about the structure of the company. He said to stay tuned until early 2024. The company reported a 14% decline in revenue for the quarter, with all three business sectors seeing a drop in sales.
Pharma Times
AUGUST 8, 2023
Therapy targets the coronavirus PLPRO enzyme essential for the evasion of host immune response - News - PharmaTimes
Fierce Pharma
AUGUST 8, 2023
Big changes are brewing at Emergent BioSolutions, as the beleaguered contract manufacturer puts its CDMO business on the back burner in a bid to shore up its core medical countermeasures and Narcan | Emergent is de-emphasizing its focus on its CDMO services business. As part of the move, Emergent will scale back operations at its Bayview facility in Baltimore, Maryland, as well as its plants in Canton, Massachusetts, and Rockville, Maryland.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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